Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro gene mutation study in bacteria:

In a reliable GLP OECD guideline 471 study (NOTOX, 2002), Lemonile was tested in a bacterial reverse mutation assay in Salmonella typhimurium (strains TA98, TA100, TA102, TA1535 and TA1537) with and without metabolic activation (S9). Lemonile did not induce a dose related increase in the number of revertant (His+) colonies in each of the five tester strains both in the absence and presence of S-9 metabolic activation. The test item, Lemonile was therefore considered to be non-mutagenic.

 

In vitro chromosome aberration study in Chinese hamster V79 cells:

In a reliable GLP OECD guideline 473 study (RCC, 2004), Lemonile was tested for its ability to induce structural chromosomal aberrations in V79 cells of the Chinese hamster in vitro in the presence and absence of metabolic activation. The test item did not induce any biologically relevant structural chromosome aberrations. Therefore, Lemonile was considered to be non-clastogenic to Chinese hamster V79 cells in vitro.

 

In vitro gene mutation study in mammalian cells:

The requirement for an in vitro gene mutation study in mammalian cells has been waived because of the existence of adequate in vivo data.

 

In vivo mutagenicity study in mammalian cells:

In a reliable GLP OECD guideline 474 study (RCC, 2005), the potential of Lemonile to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the mouse was investigated. The test item did not induce micronuclei and therefore Lemonile is considered to be non-mutagenic.


Short description of key information:
Ames test: negative (OECD 471)
Chromosome aberration test: negative (OECD 473)
Mouse micronucleus test: negative (OECD 474)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The results of an in vitro gene mutation study in bacteria, an in vitro chromosome aberration study in Chinese hamster V79 cells and an in vivo mutagenicity study in mammalian cells were all negative. Therefore, it is concluded that Lemonile is not genotoxic and does not warrant classification for mutagenicity according to CLP Regulation EC 1272/2008.